Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Chemotherapy in the Treatment of Immunoresistant Advanced Non-small Cell Lung Cancer

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Non-small-cell Lung Cancer

In brief

Objective to compare the efficacy and safety of TQB2450 injection combined with anlotinib and chemotherapy, and TQB2450 injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer subjects who failed to receive first-line chemotherapy combined with immunization, and to explore and evaluate biomarkers related to efficacy, mechanism of action / resistance mechanism, and safety.

Key facts

Study ID: NCT06141226
Run by: Tianjin Medical University Cancer Institute and Hospital
People needed: 148
Starts: 2023-04-12
Expected to finish: 2028-12-30
Last updated by the study team: 2024-09-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

According to the International Association for the Study of Lung Cancer and the Joint Committee on the American Classification of Cancer, 8th edition TNM staging of lung cancer, patients with locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) NSCLC who are histologically proven to be inoperable and unable to undergo radical synchronous radiotherapy and chemotherapy.
18 years old ≤ age ≤ 75 years old; No gender limit; ECOG score 0-1 points; The expected survival period is ≥ 3 months.
According to RECIST 1.1 standard, there should be at least one measurable lesion.
Tumor resistance has progressed after receiving first-line treatment with immune checkpoint inhibitors (including PD-1 or PD-L1 monoclonal or dual antibodies) combined with platinum based drugs in the past. For neoadjuvant/adjuvant chemotherapy or radiotherapy or concurrent radiotherapy and chemotherapy, if the disease progresses during treatment or within 6 months after discontinuation of treatment, it should be considered as a first-line treatment plan.
It is necessary to provide tumor tissue sections that have been diagnosed with advanced or metastatic NSCLC and have not undergone radiotherapy (at least 5 samples are required for PD-L1 testing of tumor tissue, but if testing has been conducted before the first line treatment, recognized test results from each participating center can be accepted.) Tumor tissue samples must be archived samples or freshly obtained samples within the first 12 months of randomization.
Except for patients with squamous NSCLC, enrolled patients need to demonstrate the absence of EGFR gene sensitive mutations, ALK fusion oncogenes, or ROS1 fusion oncogenes. If it is adenosquamous cell carcinoma, stratification needs to be determined based on the dominant tissue composition.
Good function of main organs
Women of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study. Serum pregnancy or urine pregnancy tests should be negative within 7 days before enrollment in the study; Men should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study period.
The subjects voluntarily joined this study, signed an informed consent form, and had good compliance.

You may not qualify if…

Tumor diseases and medical history:
a) If there is a central nervous system metastasis before enrollment, enrollment can be made if all the following criteria are met: i. Previously received brain metastasis treatment and met all of the following criteria:
① Only supratentorial and cerebellar metastases are allowed (i.e. transfer to the midbrain, pons, medulla, or spinal cord is not allowed);
② No imaging evidence of new or enlarged brain metastases was found;
③ There are no symptoms of brain metastasis, and the subject must have stopped using corticosteroids/dehydrating agents for at least 2 weeks before starting to use the investigational drug.
Ii. Has not received brain metastasis treatment in the past and meets all of the following criteria:
No more than 3 metastatic lesions; ② The total length and diameter of all lesions ≤ 1.5cm;
There are no neurological symptoms caused by brain tissue compression;
④ Before starting to use the investigational drug, the subject must have stopped using corticosteroids/dehydrating agents for at least 2 weeks.
b) There were no active malignant tumors for ≤ 2 years before randomization. c) Central type squamous cell carcinoma with a cavity (primary in the main bronchus and around the hilum of the lungs).
d) Imaging shows that the tumor invades large blood vessels, or the boundary between the tumor and the blood vessels is unclear, or the researcher determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies.
e) (1) Severe bone damage caused by tumor bone metastasis, including pathological fractures of load-bearing bones (such as spinal vertebrae, pelvis, femur, tibia, phalanges, calcaneus, etc.) and spinal cord compression that occur within 6 months; (2) Imaging examination suggests the presence of three or more multiple bone metastases in the load-bearing bone.
f) Patients with serous cavity (pleural, abdominal, or pericardial) effusion that requires repeated drainage to alleviate clinical symptoms (as determined by the researcher), or those who have received serous cavity effusion drainage for treatment purposes within 2 weeks prior to treatment.
Previous anti-tumor treatment:
Within 2 weeks before the start of the study treatment, he received traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the NMPA approved drug instructions.
I have previously used anti angiogenic drug systems such as arotinib, apatinib, lenvatinib, sorafenib, sunitinib, regofinib, and furoquitinib to treat locally advanced or metastatic NSCLC.
Previously received docetaxel for systematic treatment of locally advanced or metastatic NSCLC.
Unacceptable toxicity after previous anti PD - (L) 1 treatment.
Patients who have received medication with immunomodulatory effects within 30 days before starting treatment.
Before randomization, there are any symptoms that require systemic treatment with corticosteroids (prednisone or equivalent doses of similar drugs above 10 mg/d) or other immunosuppressive agents for ≤ 14 days.
Failure to recover from toxicity and/or complications of previous intervention measures to CTCAE ≤ 1 level, except for peripheral neuropathy with hair loss and ≤ 2 level.
Concomitant diseases and medical history:
a) Decompensated cirrhosis (Child Pugh liver function rating B or C), active hepatitis, and active COVID-19 infection.
b) Renal abnormalities: i. Renal failure requires hemodialysis or peritoneal dialysis; Ii. Previous or existing nephrotic syndrome (excluding cured), chronic nephritis.
c) Cardiovascular and cerebrovascular abnormalities: d) Gastrointestinal abnormalities: i. Inability to take medication orally; Ii. History of malabsorption syndrome or other diseases that can interfere with gastrointestinal absorption, including a history of partial surgical removal of the stomach or intestines (excluding appendectomy); Iii. Received treatment for active gastrointestinal ulcers within the past 6 months.

Where it is running

The First Affiliated Hospital of Nanyang Medical College — Nanyang, Henan, China (enrolling)
The Second People's Hospital of Lianyungang — Lianyungang, Jiangsu, China (enrolling)
Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (enrolling)
The Central People's Hospital of Huizhou — Huizhou, Guangdong, China
Weihai Municipal Hospital — Weihai, Shandong, China

Full record on ClinicalTrials.gov

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